Medical Device Product Development Process
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We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.
The process is a methodical approach that can be used with almost any product development process from concept to production. The speaker has a proven track record of successful products and many of them have been on the market longer than the 5 or 10 year expected product life cycle. The speaker has 20 granted patents and over 83% percent of them have been commercialized and using this process.
Why should you Attend: The medical device development process can be long and costly, but not if you follow some proven guidelines and steps. Sometimes projects are continuously pushed forward without doing proper reviews to see if the project warrants going to the next step. The sooner this process is done the better as it saves time and money. Good products also need to be completed faster and with less capital to beat the competition to market and beat them with a good quality product that needs little to no revisions and one that receives very few to no complaints from the customer. We will teach you the secrets of turning your medical device ideas into profit making products, which are the same steps that can also enable you to see why the project should be cancelled.
Areas Covered in the Session:
Who Will Benefit:
- How to start a development project.
- Patent search
- Putting together a comprehensive systems requirement document.
- 1-10-100 Rule
- Market research and customer needs
- Design in quality & manufacturability
- Prototype & testing
- Production Tooling
- Qualification, Validation, & Verification
- Trace Matrix
- Technical File & Regulatory Documentation
- Medical Device Design Engineers
- Product Managers
- Directors of Product Development
- VP of Product Development
- Project Leaders
- Technical Team Leaders
Karl R. Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle product development, product conception, polymer selection, thorough computer-aided product design, dynamic mechanical analysis and root cause analysis, molding and manufacturing, project organization, technical presentations and leadership, and cross-functional teamwork. Karl currently holds 19 patents (several patents pending), 5 design awards, was listed as one of "100 notable people in the Medical Device Industry" by Medical Device and Diagnostic Industry (MDDI), and was inducted into the Product Design & Development Engineer Hall of Fame.
Karl has a Masters of Science Degree in Mechanical Engineering from North Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering from the University of New Hampshire. He is a licensed professional engineer in New Hampshire and has lectured Medical Device and Manufacturing (MD&M) Seminars on The Science of Successful Product Design.
Karl Leinsing serves on Eureka Medical's Board of Advisors and reviews and evaluates new medical product ideas for this company along with its other distinguished members. He also serves on the Inventor's Workshop Board of Directors to review new products for the promotional and retail industry.